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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Network And Communication, Physiological Monitors
510(k) Number K233418
Device Name Biofourmis Everion+ (G2)
Applicant
Biofourmis Singapore Pte., Ltd.
2 Venture Dr., Vision Exchange, #23-01
Singapore,  SG 608526
Applicant Contact Seth Kuzdzal
Correspondent
Biofourmis Singapore Pte., Ltd.
2 Venture Dr., Vision Exchange, #23-01
Singapore,  SG 608526
Correspondent Contact Seth Kuzdzal
Regulation Number870.2300
Classification Product Code
MSX  
Subsequent Product Codes
BZQ   DQA   DRG   MWI  
Date Received10/10/2023
Decision Date 05/09/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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